Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02385968

Enrollment

Registered

2015-03-11

Start date

2014-10-31

Completion date

2016-10-31

Last updated

2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Disc Herniations

Keywords

Modic, Microbiology, Immunology

Brief summary

The aim is to investigate if herniated nucleus material in lumbar disc herniations is infected with bacteria, and if so, to determine their prevalence (control group), and to determine if patients with pre-existing Modic changes type 1 have a higher incidence of bacterial growth in relevant lumbar disc samples than patients without Modic changes. A cohort of 15 patients with pre-existing Modic and 15 without-undergoing primary surgery will be examined.

Detailed description

The nucleus material will be evacuated and divided into 5 biopsies, each with a new set of sterile instruments and placed in separate sterile glass vials with one drop of sterile saline to prevent drying of biopsy. The primary outcome, i.e., bacterial growth on a per-patient basis. Bacterial growth shall be detected in minimum 3 out of 5 biopsies for the patient to be scored as positive for bacteria.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* MRI-confirmed lumbar disc herniation. * Age between 18 and 65 years. * No prior spine surgery. * No diagnosed dementia.

Exclusion criteria

* Antibiotic treatment within the previous two weeks. * History of alcohol abuse, illicit drug use or drug abuse, or significant mental illness * Known immune deficiency state (e.g., positive for human immunodeficiency virus) or in treatment with immunosuppressive drugs including high dose steroids or cyclosporine. * Concurrent infections (infections of skin, urinary tract infection, other skin diseases, e.g. Acne vulgaris). * Previous epidural instrumentation. * Uncontrolled, unstable or recently diagnosed autoimmune disease, including but not limited to systemic lupus erythematosus, inflammatory bowel disease, sarcoidosis, rheumatoid arthritis, or psoriasis.

Design outcomes

Primary

Measure	Time frame
Bacterial growth on a per-patient basis	at time of surgery

Countries

Denmark

Outcome results